Chemotherapy Combined With Adebrelimab and Mecapegfilgrastim in Neoadjuvant Treatment of Potentially Resectable BTC

NCT06037655 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: MA-BTC-II-002
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to assess the safety and efficacy of Gemcitabine/cisplatin combined with Adebrelimab and Mecapegfilgrastim in neoadjuvant treatment of potentially resectable Biliary Tract Neoplasms.

Conditions

Biliary Tract Neoplasms

Outcome Measures

Primary Outcomes (1)

• Objective response rate (ORR)

  ORR is defined as patients achieving clinical complete response (CR) or partial response (PR) according to RECIST v1.1

  18 weeks

Secondary Outcomes (1)

• overall survival (OS)

  2 years

Other Outcomes (3)

• Progression free survival (PFS)

  2 years

• Pathological Complete Response Rate (pCR)

  18 weeks

• Major Pathological Response Rate (MPR)

  18 weeks

Study Arms (1)

Experimental

EXPERIMENTAL

NeoAdjuvant Therapy with Adebrelimab plus Mecapegfilgrastim and Gemcitabine/cisplatin followed by the operation

Drug: Total Neoadjuvant Treatment

Interventions

Total Neoadjuvant Treatment DRUG

Adebrelimab (1200 mg) every three weeks intravenously; Mecapegfilgrastim (6 mg) every three weeks intravenously; Gemcitabine (1000 mg/m2) every three weeks on days 1 and 8 intravenously; Cisplatin (25 mg/m2) every three weeks on days 1 and 8 intravenously

Experimental

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female
• Age ≥ 18 years，≤ 75 years
• Patients with untreated resectable locally advanced biliary tract cancer (BTC) who are difficult to directly resecte surgically
• Ability to provide written informed consent prior to participation in any study-related procedure
• Eastern Cooperative Oncology Group (ECOG) performance status 0-1
• At least one, not previously irradiated, measurable lesion according to RECIST (version 1.1).
• Adequate organ function

You may not qualify if:

• Diagnosis of mixed ampullary, hepatocellular, and cholangiocarcinoma
• Known history of a serious allergy to any monoclonal antibody
• Any active malignancy prior to the start of treatment
• Active or history of autoimmune disease
• Other acute or chronic conditions, psychiatric disorders, or laboratory abnormalities that may increase the risk of study participation
• Pregnant or lactating women

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead

MeSH Terms

Conditions

Biliary Tract Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Biliary Tract Diseases; Digestive System Diseases

Study Officials

• Xiangcheng Li

  The First Affiliated Hospital with Nanjing Medical University

  STUDY CHAIR

• Xiaofeng Chen

  The First Affiliated Hospital with Nanjing Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiangcheng Li

CONTACT

18951999088; drlixc@163.com

Xiaofeng Chen

CONTACT

13585172066

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2023
• First Posted: September 14, 2023
• Study Start: September 25, 2023
• Primary Completion: March 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: September 14, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share